MAUDE Adverse Event Report: SYNTHES USA 2.0MM KIRSCHNER WIRE W/TROCAR POINT 150MM; PIN, FIXATION, SMOOTH

Catalog Number 292.20

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 03/02/2015

Event Type  malfunction  

Event Description

It was reported that a k-wire broke during a procedure to repair an olecranon fracture.As the surgeon was putting on the olecranon plate and started to pin it down with k-wire, it broke.A partial piece of the wire was left in the patient.There were no delays reported and the procedure was successfully completed.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: investigation could not be completed and no conclusion could be drawn as no device was returned and no lot was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(6).Device is an instrument and is not implanted/explanted.Device initially reported as adverse event and product problem/malfunction.Device should be product problem/malfunction only.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).A product development investigation was performed for the subject device.The tip of the returned device is broken off and was not returned.Since the tip was not returned, the exact part number could not be confirmed with respect to the reported part number.There are multiple roll marks on the shaft of the device.It is unknown what caused the complaint condition, but it is likely that off axis forces contributed to the failure of the device.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.Although the exact cause cannot be determined, this complaint condition is likely a result of method of use and not the device's design.Because of this, the complaint is determined not to be a result of a detected design deficiency.The returned part is determined to be suitable for their intended use when used and maintained as recommended.This complaint is confirmed, but the design of the device did not contribute to this complaint.Event is serious injury for device fragment in patient and product problem.Required intervention.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.0MM KIRSCHNER WIRE W/TROCAR POINT 150MM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4628272
• MDR Text Key: 17998554
• Report Number: 2520274-2015-12058
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PPREAMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 292.20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 03/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/10/2015; 04/23/2015; 06/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR